glycopyrrolate

Generic: glycopyrrolate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycopyrrolate
Generic Name glycopyrrolate
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

glycopyrrolate 1 mg/5mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-104
Product ID 65145-104_b112c5d5-5992-4b6d-8832-cafe5fdcf87b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211705
Listing Expiration 2026-12-31
Marketing Start 2025-01-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145104
Hyphenated Format 65145-104

Supplemental Identifiers

RxCUI
238212 1731582 1731590
UPC
0365145105011 0365145102010 0365145103017 0365145104014 0365145105103
UNII
V92SO9WP2I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name glycopyrrolate (source: ndc)
Generic Name glycopyrrolate (source: ndc)
Application Number ANDA211705 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (65145-104-25) / 5 mL in 1 VIAL, MULTI-DOSE (65145-104-01)
source: ndc

Packages (1)

65145-104-25 25 VIAL, MULTI-DOSE in 1 CARTON (65145-104-25) / 5 mL in 1 VIAL, MULTI-DOSE (65145-104-01)

Ingredients (1)

glycopyrrolate (1 mg/5mL)

Linked Drug Pages (1)

Glycopyrrolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b112c5d5-5992-4b6d-8832-cafe5fdcf87b", "openfda": {"upc": ["0365145105011", "0365145102010", "0365145103017", "0365145104014", "0365145105103"], "unii": ["V92SO9WP2I"], "rxcui": ["238212", "1731582", "1731590"], "spl_set_id": ["765490fa-8378-40c8-9fa7-b0bfa2e1a0a9"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (65145-104-25)  / 5 mL in 1 VIAL, MULTI-DOSE (65145-104-01)", "package_ndc": "65145-104-25", "marketing_start_date": "20250125"}], "brand_name": "Glycopyrrolate", "product_id": "65145-104_b112c5d5-5992-4b6d-8832-cafe5fdcf87b", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "65145-104", "generic_name": "Glycopyrrolate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycopyrrolate", "active_ingredients": [{"name": "GLYCOPYRROLATE", "strength": "1 mg/5mL"}], "application_number": "ANDA211705", "marketing_category": "ANDA", "marketing_start_date": "20250125", "listing_expiration_date": "20261231"}